Kornimate/medical-research-clean huggingface dataset:
evaluation of the effectiveness of an amnion-chorion membrane for alveolar ridge preservation

Conditions: Healing Wound

Summary: this study will examine whether adding an amnion-chorion membrane on top of the traditionally used collagen plug will lead to more bone formation compared to the collagen plug only.

bone grafts and membranes are commonly placed to increase the amount of bone right after tooth extraction and before placing a dental implant. the primary objective of this study is to study the effect of a human amnion-chorion membrane (acm) in an exposed-barrier ridge preservation technique to a control group without utilizing a acm. 30 patients requiring a front tooth extraction will be recruited and randomized to receive bone grafting with or without an acm.

Eligibility criteria:
inclusion criteria: 1. age range: 20 to 80 years. 2. patients must require tooth extraction (for incisors, canines and premolars) as a result of caries, periodontal disease, tooth fracture or deemed unrestorable. 3. socket should be free of infection, less than 5mm of dehiscence 4. patients interested in implant placement following tooth extraction. exclusion criteria: 1. allergies or hypersensitivities to study related medications such as chlorhexidine. 2. hematologic disorders/blood dyscrasias. 3. active infectious diseases of any kind. 4. liver or kidney dysfunction/failure. 5. uncontrolled diabetes (hba1c \> 8). 6. active cancer treatment - such as active chemotherapy or radiation therapy. 7. taking medications that will affect their bone healing (for example, bisphosphonates). 8. metabolic bone diseases that affect bone healing such as osteoporosis. 9. pregnant or lactating women (self-reported). 10. smoke 10 or more cigarettes per day (self-reported). 11. poor oral hygiene.
a first time in human study of pin201104 in healthy volunteers and patients with asthma

Conditions: Healthy Volunteers; Asthma

Summary: the purpose of this study is to assess the safety, tolerability and pharmacokinetics of different single and repeat doses of pin201104 in healthy volunteers and in patients with asthma.


Eligibility criteria:
inclusion criteria: * healthy male and female subjects of non-childbearing potential age 18 to 65 years of age, and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests. * written informed consent must be obtained before any assessment is performed. * able to communicate well with the investigator/designee. exclusion criteria: * any known reaction to study drug or components * concurrent or recent infection or clinically significant conditions that may place subject at risk or interference with absorption, distribution or excretion of drugs * no qtcf interval ≥450 milliseconds, no qrs complex ≥120 milliseconds, at screening * positive test results for hepatitis b surface antigen (hbsag), hepatitis c virus antibodies (hcvab) or human immunodeficiency virus (hiv) 1 and/or -2 antibodies at screening. * excessive use of caffeine-containing beverages * urinary cotinine level indicative of smoking or history or regular use of tobacco- or nicotine containing products within 6 months before screening. * history of regular alcohol consumption within 6 months of screening 10. * positive screen for drugs-of-abuse or cotinine. * blood donation in excess of 500ml within 3 months. * participation in another study with an experimental drug within 3 months of first imp administration. * exposure to more than 4 new chemical entities within 12 months before the first imp administration. * ongoing rhinitis that requires treatment. * use of live vaccine 28 days before dosing with study drug until telephone follow-up and use of killed vaccine 14 days before dosing with study drug until telephone follow-up.
tools for health and resilience implemented after violence exposure (project thrive)

Conditions: Post Traumatic Stress Disorder; Problem Drinking

Summary: sexual assault victimization is a common and particularly harmful form of trauma that is associated with increased risk for high-risk drinking and other conditions of public health concern, such as ptsd. given evidence that sexual assault survivors who have low social support or receive negative social reactions to sexual assault disclosure are more likely to experience ptsd and drinking problems, improving social support is a novel target for intervention. the proposed study will attempt to prevent the onset of high-risk drinking and ptsd in sexual assault survivors by developing and testing a web-based early intervention aimed at increasing contact with social supporters and mitigating the harm of negative social reactions; ultimately, results will contribute to advancing the field's understanding of the potential for social support to mitigate the harm of trauma.

this study involves developing, modifying, and preliminarily testing an intervention to prevent high-risk drinking and ptsd in women who have experienced sexual assault (sa) in the past 10 weeks. in the pilot trial phase of this study, intervention feasibility will be tested in an open trial with n = 40 women with past-10-week sa histories, active drinking, and elevated distress. participants will complete surveys at baseline, termination, and 3-month follow-up. participants will be randomized to either the intervention (n = 20) or assessment-only control (n = 20). we hypothesize that (h1) most participants will respond positively on items assessing satisfaction with the intervention, (h2) participants will report above-average usability on a standardized measure, (h3) completion rates for daily activities will be similar to previous web-based interventions, (h4) participants will show significant learning as evidenced by increases in correct responses to knowledge questions from baseline to post, and (h5) participants in the intervention condition will evidence less high-risk drinking and ptsd at 3-month follow-up than participants in the assessment-only condition.

Eligibility criteria:
inclusion criteria: * informed consent * self-identification as female * sexual assault, defined as endorsement of unwanted, attempted or completed sexual contact in the past 10 weeks * age \> 18 * english fluency * smartphone and internet access at least daily for 3 weeks and at least weekly for 3 months * consumption of \>1 alcoholic drink in the past month * \>1 episode of high-risk drinking in past 6 months, defined as either more than 3 drinks on a given day or more than 7 drinks in a given week * at least 3 symptom clusters endorsed on the ptsd checklist. exclusion criteria: * active suicidality * psychosis
efficacy of oxytocin vs. carbetocin in prevention of postpartum hemorrhage after cesarean section

Conditions: Postpartum Hemorrhage

Summary: postpartum hemorrhage (pph) is a common complication of childbirth and a leading cause of maternal morbidity and mortality. the prompt and effective treatment of subjects with pph would reduce operation risks. hence in this study, the efficacy of oxytocin and carbetocin was compared in prevention of postpartum hemorrhage after cesarean sections.


Eligibility criteria:
inclusion criteria: * at least one risk for postpartum hemorrhage and lack of hypersensitivity to oxytocin and carbetocin exclusion criteria: * patients' refusal to cooperate, major therapeutic side effects, history of cardiac and renal disease or preeclampsia

Keywords: prevention cesarean section
effect of combined morphine and duloxetine on chronic pain

Conditions: Chronic Low Back Pain; Chronic Neck Pain

Summary: a double-blind, randomized, and placebo-controlled clinical study examining whether duloxetine, a serotonin and norepinephrine reuptake inhibitor (snri), could enhance opioid analgesia and reduce overall opioid use. positive outcomes will help improve the overall effectiveness of clinical opioid therapy and reduce unnecessary opioid dose escalation.

subjects will participate in a 10-week study consisting of three phases: phase i is the dose titration period of 4 weeks, phase ii is the dose maintenance period of 4 weeks, and phase iii is the dose taper period of 2 weeks. seven office visits (initial visit/baseline, weeks 1, 3, 5, 7, 9, and end of week 10) and four follow up phone calls (weeks 2, 4, 6, and 10) will be used to collect data. since this is a prospective study, we will be able to first determine baseline qst and vas pain score, followed by assessing their longitudinal changes at each office visit. to assess oih, qst will be performed at each office visit before subject takes the next dose of the study drugs. we will also measure plasma morphine concentration during the titration and maintenance phase to help validate morphine intake.

Eligibility criteria:
inclusion criteria: 1. subject is 18-70 years old. 2. subject has chronic neck or back pain for at least 3 months. 3. subject has a vas ≥ 5. 4. has not taken duloxetine in the last 3 months. 5. has not taken an opioid in the last 3 months, but has taken one in the past without sufficient pain control or has never taken opioids but has failed at 3 (or more) non-opioid treatments. exclusion criteria: 1. subject has major psychiatric disorders requiring recent hospitalization (within 3 months) such as major depression, bipolar disorder, schizophrenia, anxiety disorder, or psychotic disorder. 2. subject is using illicit drugs detected by urine toxicology/drug screen. 3. subject is pregnant or lactating/breast feeding. 4. subject is allergic to morphine or duloxetine. 5. subject is on an antidepressant including serotonin-norepinephrine reuptake inhibitors (snri), selective serotonin reuptake inhibitor (ssri), tricyclic antidepressant. 6. subject has a history of suicidal attempts or current suicidal ideation. 7. subject takes monoamine oxidase inhibitors, antipsychotics, triptan drugs such as sumatriptan, lithium, linezolid, tramadol (ultram), st. john's wort, central nervous system (cns) stimulants such as amphetamine, methylphenidate, methamphetamine, phentermine, diethylpropion, sibutramine, cocaine, or thioridazine. 8. subject has uncontrolled narrow-angle glaucoma. 9. subject has sensory deficits on arms or raynaud's syndrome. 10. subject has a pending litigation related to chronic pain condition. 11. subject is on methadone or suboxone treatment for addiction.

Keywords: pain pain management
next generation pathogen sequencing for prediction of adverse events

Conditions: Bloodstream Infection

Summary: the majority of children and adolescents diagnosed with cancer will experience one or more episodes of fever or infection during their course of therapy. the most common microbiologically documented infection is bloodstream infection (bsi), which can be associated with severe sepsis or death. current methods of diagnosis require a significant load of live bacteria in the blood making early detection difficult. delayed diagnosis and delayed optimal therapy of bsis are associated with increased morbidity and mortality. this study seeks to identify whether next generation sequencing (ngs) of pathogens can identify patients with impending bloodstream infection. this would enable preemptive targeted therapy to replace antibacterial prophylaxis which often leads ot high-density broad-spectrum antibiotic exposure and contributes to subsequent development of antibiotic resistance. primary objective: * to estimate the sensitivity and specificity of next generation pathogen sequencing for prediction of bloodstream infection in children with cancer at high risk of infection.

plasma samples collected but not required for clinical care (discarded samples) will be collected and stored. results of ngs will be compared between patients who develop bsi immediately (within 72 hours) after sample collection, those who develop other infectious syndromes, and those who remain well. clinical data describing baseline information about the patient and malignancy, antibiotic and chemotherapy exposure, microbiology testing, hematology results, and infection-related events will be collected prospectively from the electronic medical record. an initial exploratory phase will examine approximately 50 participants to determine whether the effectiveness of predicting infections. the study may then enroll up to 200 participants to collection additional data for analysis.

Eligibility criteria:
inclusion criteria: * under 25 years of age at time of study enrollment * undergoing care for cancer at st. jude * in a category of patients who are considered by the investigator to be at high risk of infection * expected to receive care at st. jude for at least 7 days exclusion criteria: * any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

Keywords: next generation pathogen sequencing (ngps) pediatric cancer bloodstream infection (bsi)
sevoflurane insufflation vs intravenous sedation for radiotherapy in pediatric patients

Conditions: Pediatric Sedation; Radiotherapy; Inhalation Anesthesia

Summary: aim of this cross-over study is to compare sedation with insufflated sevoflurane and intravenous sedation for pediatric radiotherapy patients

aim of this cross-over study is to compare sedation with insufflated sevoflurane and intravenous sedation for pediatric radiotherapy(rt) patients in terms of success of the procedure (continuous completion of the rt session by providing inactivity) and complications such as desaturation, hypoventilation, airway spasm, bradycardia, tachycardia in addition, we aimed to investigate the incidence of anesthesia complications in rt patients and possible related factors with complications.

Eligibility criteria:
inclusion criteria: * undergoing radiotherapy session exclusion criteria: * family refusal * chronic nausea and vomiting * apnea history, pneumonia, asthma, bronchiolitis etc. respiratory tract infection or diseases * cardiac disease * kidney failure * liver failure * anticipated difficult airway * metabolic diseases * neurological or muscular diseases.

Keywords: insufflation sedation intravenous sedation radiotherapy anesthesia pediatric sedation
a phase ii study of postoperative s-1-based chemoradiotherapy in gastric cancer

Conditions: Stomach Neoplasms; Chemoradiotherapy, Adjuvant; Radiotherapy, Intensity-Modulated

Summary: the aim of this phase ii trial was to evaluate the feasibility, efficacy and tolerability of intensity-modulated radiotherapy combined with s-1 based chemotherapy in patients with pathologically positive lymph node after completely resected gastric cancer. furthermore, the investigators sought to compare the dosimetric differences between the volumetric-modulated arc therapy (vmat), tomotherapy and intensity-modulated radiotherapy (imrt) techniques in treatment planning for gastric cancer as adjuvant radiotherapy.


Eligibility criteria:
inclusion criteria: * pathologically proven positive lymph node gastric adenocarcinoma in patients undergoing r0 resection * any prior chemotherapy is allowed in this protocol * no distant metastasis in liver,lung,,bone,central nervous system(cns),no peritoneal transplantation * no prior abdominal or pelvic radiotherapy * karnofsky performance status(kps)≥ 70, predictive life span no less than 6 months * patients must have normal organ and marrow function as defined below: * leukocytes greater than or equal to 3,000 g/l * platelets: greater than or equal to 100,000/mm3 * hemoglobin:greater than or equal to 10g/l * total bilirubin: within normal institutional limits * ast/alt: less than or equal to 1.5 times the upper limit * creatinine within normal upper limits * informed consent exclusion criteria: * patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer * with any distant metastasis in liver,lung,,bone,cns,or peritoneal transplantation * history of allergic reactions attributed to similar chemical or biologic complex to s-1 * uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness * history of myocardial infarction within the past 6 months or history of ventricular arrhythmia * history of prior radiation to the abdomen * pregnant or lactating females
cyclosporine a in cardiac arrest

Conditions: Non Shockable Out of Hospital Cardiac Arrest

Summary: the investigators hypothesised that cyclosporine a administration at the onset of cardiopulmonary resuscitation, by inhibiting the mitochondrial permeability transition pore, could prevent the post cardiac arrest syndrome and improve outcomes.


Eligibility criteria:
inclusion criteria: * witnessed out-of-hospital cardiac arrest * non shockable cardiac rhythm exclusion criteria: * evidence of trauma * evidence of pregnancy * duration of no flow more than 30 minutes * rapidly fatal underlying disease * allergy to cyclosporin a

Keywords: cardiac arrest heart arrest cyclosporine a post cardiac arrest syndrome protective agent multiple organ failure mitochondrial permeability transition pore mitochondria cardio-pulmonary resuscitation cardioprotection ischemia reperfusion postconditioning
long-term safety and efficacy study of teduglutide in pediatric participants with short bowel syndrome (sbs)

Conditions: Short Bowel Syndrome

Summary: this study will follow participants who completed the ted-c14-006 study. the purpose of this study is to evaluate the long-term safety and efficacy of teduglutide in pediatric participants with short bowel syndrome (sbs). this study will also offer teduglutide treatment to eligible participants, regardless of treatment received in ted-c14-006 or shp633-301.


Eligibility criteria:
inclusion criteria: 1. participant provides written informed consent (participant, parent or legal guardian and, as appropriate, informed assent) to participate in the study before completing any study-related procedures. 2. participant completed the ted-c14-006 or shp633-301 studies (including participants in the standard of care treatment arms). participants are considered to have completed shp633-301 if they completed study assessments through week 24. 3. participant understands and is willing and able to fully adhere to study requirements as defined in this protocol. exclusion criteria: 1. there are no exclusion criteria for this study.
a phase ii study of 131i-rituximab for relapsed/refractory diffuse large b cell lymphoma (dlbcl)

Conditions: Relapsed or Refractory Diffuse Large B Cell Lymphoma

Summary: diffuse large b cell lymphoma (dlbcl) is the most common type of non-hodgkin lymphoma in korea. although there is standard therapy, which is called 'r-chop', many obstacles to use aggressive cytotoxic chemotherapeutic agents such as old age, poor performance status, refractoriness, and relapsed disease still remains. so we investigate the efficacy of radioimmunotherapy using 131i-rituximab in refractory or relapsed patients with dlbcl.


Eligibility criteria:
inclusion criteria: * histologically confirmed diffuse large b cell lymphoma elderly (\>65 years) or medically ineligible to standard cytotoxic chemotherapy due to poor performance status, or relapsed or refractory patients eastern cooperative oncology group performance status ≤ 2, age≥ 20 years relapsed or refractory after autologous hematopoietic stem cell transplantation (auto-hsct) in young patients with good performance status and indicated to high dose chemotherapy and auto-hsct more than one measurable lesion * more than 2cm sized lesion in conventional ct scan, * more than 1cm sized lesion in spiral ct or contrast-enhanced pet/ct adequate renal function (serum creatinine ≤ 2.0 mg/dl or ccr ≥ 60 ml/min) adequate hepatic function (serum bilirubin ≤ 2.0 mg/dl , ast/alt ≤ 3 upper normal limit) adequate bone marrow reservoir (anc ≥1,500/㎕, platelet count≥ 75,000/㎕) patient who agree the purpose and intention of this clinical trial exclusion criteria: * recent (\<5 years) history of other malignancy or unrecovered from the disease (appropriately treated skin cancer and uterine cervix carcinoma in situ are excluded) * hemodynamically unstable due to the recent (\<12 months) history of severe heart disease such as myocardial infarction * acute complications of severe lung or metabolic disease * combined severe neurological or psychiatric disease unrecovered from infection or other medical disease recent (\<30 days) history of enrollment of other clinical trial pregnant or breast-feeding woman women of childbearing potential and men not employing adequate contraception at least for 1 year previous history drug allergy to the content of 131i-rituximab infection(sepsis, pneumonia, viral infection, etc) (inactivated hepatitis b carrier can be enrolled) young patient with good performance status indicated to autologous hematopoietic stem cell transplantation irrespective of the failure of 1st line chemotherapy

Keywords: diffuse large b cell lymphoma radioimmunotherapy 131i-rituximab
measuring and reducing excessive infant crying

Conditions: Infant Colic; Postpartum Depression

Summary: excessive infant crying (eic) is likely to increase the risk of child abuse. the investigators propose a randomized trial using an intervention based on recommendations of karp. the investigators will systematically identify 170 term infants with eic and conduct assessments in the home at 6-8 weeks age to test the hypothesis that the intervention reduces mean infant hours of night-time crying, increases maternal soothing behaviors and improves parental anxiety and depression.

hypotheses: the soothing techniques taught to study parents 2-3 wks after birth augment parental soothing skills and reduces infant crying at night (primary outcome) and parental sleep loss, distress, \& depression assessed in the home by a masked nurse at 8 wks. methods: term singleton infants with eic (\> 3 hrs/24h) recruited through a program offered to parents at our hospital (4,700 births/yr) will be seen in our clinic 2-3 wks after birth. consenting families (n=178) will be randomized to standard colic counseling (american academy of pediatrics) or to the intervention (adding nurse instruction plus a video and pamphlets). at 8 wks a study nurse will assess parental sleep and distress (brief symptom inventory-18), place dosimeters in rooms where the infant sleeps and spends most time, and apply the actigraph at the ankle. she will collect the devices 5 days later, perform a physical exam at a usual feeding time (when eic is likely), record infant \& maternal behaviors during crying/feeding for the next 15 minutes using unobtrusive, validated methods (tyson, 1992), and provide maternal support if desired. standard statistical tests will be used (alpha=0.05; beta = 0.20; effect size =0.5 sd, power = .90).

Eligibility criteria:
inclusion criteria: * term, singleton neonates * otherwise healthy * parent must have at least a 6th grade understanding of english or spanish * infant must have colic (greater than 3 hours of crying per day) * or the infant's crying causes excessive stress on the either parent exclusion criteria: * cannot have a condition which would reasonably impact alertness or behavior

Keywords: randomized trial infant colic abusive head trauma shaken baby syndrome